Premium
Results of the multicenter first‐in‐man study of a novel scoring balloon catheter for the treatment of infra‐popliteal peripheral arterial disease
Author(s) -
Scheinert Dierk,
Peeters Patrick,
Bosiers Marc,
O'Sullivan Gerry,
Sultan Sherif,
Gershony Gary
Publication year - 2007
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.21341
Subject(s) - medicine , balloon , percutaneous , amputation , surgery , radiology , critical limb ischemia , lesion , catheter , popliteal artery , balloon catheter , calcification , peripheral , target lesion , angioplasty , vascular disease , arterial disease , cardiology , percutaneous coronary intervention , myocardial infarction
Objective: To evaluate the AngioSculpt® (ASC), a novel scoring balloon catheter designed to treat complex diffuse fibro‐calcific atherosclerotic lesions and avoid device slippage during deployment, in patients with infra‐popliteal disease. Methods: The ASC incorporates a flexible nitinol scoring element containing three or more spiral struts which encircle a minimally compliant balloon to create focal concentration of the dilating force. Patients scheduled for percutaneous intervention of infra‐popliteal arteries or planned amputation and with a reference vessel diameter of 1.5–3.5 mm were included in the study. Results: A total of 42 patients and 56 lesions were treated at five sites. Of these, 38 patients (90.5%) presented with critical limb ischemia (Rutherford Class ≥ 4). The ASC was successfully deployed in 98.2% (55/56) of lesions attempted and was used as primary therapy without stenting in 89.3% (50/56). Lesion morphology was complex, including moderate/severe calcification in 73%, lesion length 33.9 ± 42.2 mm, bifurcation in 26.8%, and ostial in 12.5%. There was no significant device slippage and no perforations. Post‐ASC dissections occurred in only six (10.7%) lesions and were minor or resolved with stenting. In 13 patients initially referred for amputation, ASC treatment resulted in limb salvage. Conclusions: The ASC is highly effective in a broad range of complex lesion morphologies, in most cases as stand‐alone therapy, is associated with a very low complication rate and avoids device slippage during deployment. Additional studies are planned to assess the long term efficacy of this promising new technology. © 2007 Wiley‐Liss, Inc.